Trial Outcomes & Findings for PREMIX vs PREMED Intranasal Lidocaine and Midazolam (NCT NCT03054844)
NCT ID: NCT03054844
Last Updated: 2019-09-11
Results Overview
The Observational Scale of Behavioral Distress-Revised (OSBD-R) is an observational measure of pain and distress shown to have strong validity in children. The scale is an 8-factor, weighted observational scale used to measure distress associated with medical procedures, which has been validated in children and adults aged 1 to 20 years. The total Observational Scale of Behavioral Distress-Revised score is the sum of the scale scores for each phase, with each phase assigned a score from 0 to 23.5 units on a scale (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a predetermined number of 15-second intervals during each phase. There were four phases so the range of scores for the total OSBD-R was 0 to 94 units on a scale, with a higher score indicated a greater degree of distress.
COMPLETED
PHASE2
55 participants
10 minutes
2019-09-11
Participant Flow
Participant milestones
| Measure |
PREMED
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
27
|
|
Overall Study
COMPLETED
|
25
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
PREMIX vs PREMED Intranasal Lidocaine and Midazolam
Baseline characteristics by cohort
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
2 years
n=5 Participants
|
2 years
n=7 Participants
|
2 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 minutesThe Observational Scale of Behavioral Distress-Revised (OSBD-R) is an observational measure of pain and distress shown to have strong validity in children. The scale is an 8-factor, weighted observational scale used to measure distress associated with medical procedures, which has been validated in children and adults aged 1 to 20 years. The total Observational Scale of Behavioral Distress-Revised score is the sum of the scale scores for each phase, with each phase assigned a score from 0 to 23.5 units on a scale (0=no distress, 23.5=maximum distress), based on the frequency and types of behaviors observed during a predetermined number of 15-second intervals during each phase. There were four phases so the range of scores for the total OSBD-R was 0 to 94 units on a scale, with a higher score indicated a greater degree of distress.
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Procedural Distress, OSBD-R
|
6.4 Units on a scale
Interval 5.0 to 7.8
|
7 Units on a scale
Interval 5.2 to 8.9
|
SECONDARY outcome
Timeframe: 10 minutesThe Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) utilizes six observational factors (cry, facial, verbal, torso, touch, and legs) to evaluate pain in young children and can be used to monitor the effectiveness of interventions for reducing the pain and discomfort of an intervention. This scale rates each behavior numerically, with a score of 4-6 units on a scale representing no pain, and a maximum score of 13 units on a scale representing (most pain perceived).
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Procedural Pain
|
10.6 Units on a scale
Interval 9.7 to 11.4
|
10.5 Units on a scale
Interval 9.5 to 11.4
|
SECONDARY outcome
Timeframe: 10 minutesThe Faces, Legs, Activity, Cry, Consolability (FLACC) scale is comprised of five criteria (face, legs, activity, cry, consolability), with a possible score of 0 to 2 units on a scale for each criteria and a possible total score of 0 to 10 units on a scale (0 meaning no pain, 10 meaning most pain).
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Procedural Distress, FLACC
|
6.7 Units on a scale
Interval 5.3 to 8.1
|
7 Units on a scale
Interval 5.4 to 8.6
|
SECONDARY outcome
Timeframe: 10 minutesCry duration was measured in seconds and defined as the time from onset of crying following administration of an IN medication until the cessation of crying sounds and/or tears. If a patient did not cry, the cry duration was zero
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Procedural Distress, Cry Duration
|
84 seconds
Interval 58.0 to 109.0
|
73 seconds
Interval 45.0 to 102.0
|
SECONDARY outcome
Timeframe: 1 minuteIf my child needed medications to stay calm for a procedure, I would like to use these same medications again.
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Parental Satisfaction
|
10 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 1 minuteI would like to use this method of administering intranasal midazolam and lidocaine again in the future
Outcome measures
| Measure |
PREMED
n=25 Participants
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 Participants
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Provider Satisfaction
|
8 Participants
|
24 Participants
|
Adverse Events
PREMED
PREMIX
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
PREMED
n=25 participants at risk
Patients will receive 0.25 mL of IN 4% lidocaine (10 mg) in each naris (total of 0.5 mL/20 mg for both nares) preceding adminstration of IN midazolam.
Lidocaine: Lidocaine will be administered before administration of midazolam.
Midazolam: Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
|
PREMIX
n=26 participants at risk
Patients will receive midazolam mixed with 0.5 mL of 4% lidocaine (20 mg).
Lidocaine and midazolam (PREMIX): Lidocaine will be administered as a mixture with midazolam.
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
12.0%
3/25 • Course of ED visit, typically between 1-2 hours
|
0.00%
0/26 • Course of ED visit, typically between 1-2 hours
|
|
General disorders
Epistaxis
|
4.0%
1/25 • Course of ED visit, typically between 1-2 hours
|
0.00%
0/26 • Course of ED visit, typically between 1-2 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place